FDA recall Z-0440-2021

Product

Class IV New Era medical laser device

Reason for recall

The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2020-01-29

Report date

2020-11-25

Voluntary/Mandated

FDA Mandated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2021